MAUDE Adverse Event Report: ETHICON INC. EB EXC GRN 8X18IN 0 S/A MO-7 CR; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Catalog Number	CX41D
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and suture was used.It was reported that the needles were coming off of the suture without focus.Simply pulling the suture through tissue and the needle was popping off.Surgical delay unknown.There were no patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 4/22/2025.H6 component code: g07002 - no device problem found.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Additional information was requested, the following was obtained: - were there any adverse consequences associated with the patient? no - when were the needles detached/pulled off from the sutures (in the package, during removal from package, during handling prior to use on patient or during use on the patient)? please specify during use on the patient - did the surgery extend due to this alleged deficiency? unknown if yes, ¿ were there any unexpected outcomes or complications resulting from the prolonged surgery time? no ¿ how long, in minutes, did the surgery prolong? unknown ¿ which tissue was being sutured when the event occurred? unknown (umbilical hernia repair) ¿ was additional dissection required in other organs/tissues other than the target tissue? unknown ¿ was there any change in the patient¿s post operative care due to the prolonged procedure? unknown - could you kindly perform the follow-up attempt for the product return? please ensure that the shipment tracking number is provided ¿ i have not received the shipping kit to send back.- please provide the source or name of person providing answers to follow-up questions: (please refer the attached email).H3 investigational summary: the product was returned to ethicon for evaluation.Eight representative unopened samples were received for analysis.Upon initial inspection of the samples, no external damages were observed on the external packets.In order to evaluate the conditions of the returned samples, the packets were opened, and no defects were detected.The swage and attachment area were noted to be as expected.The sutures were dispensed without problems and examined along the strand to detect any issue related, no defects were observed during evaluation.A functional test was performed using instron equipment, and the pull force results were above the minimum requirements.The event described could not be confirmed as the device performed without any defect noted.It should be noted that as part of our quality process, each batch is randomly inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.The event described could not be confirmed as no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.

• Brand Name: EB EXC GRN 8X18IN 0 S/A MO-7 CR
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km 8.3; san lorenzo PR 00754 ; * 00754
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 21881416
• Report Number: 2210968-2025-04340
• Device Sequence Number: 15645552
• Product Code: GAT
• UDI-Device Identifier: 10705031024281
• UDI-Public: (01)10705031024281(17)290731(10)1034EA
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K946173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/22/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: CX41D
• Device Lot Number: 1034EA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2025
• Initial Report FDA Received Date: 04/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/30/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown